Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EFAVIRENZ
PAHANG PHARMACY SDN. BHD.
EFAVIRENZ
30 Tablets
Mylan Laboratories Limited
_Consumer Medication Information Leaflet (RiMUP) _ EFAMAT TABLETS Efavirenz (200mg, 600mg) 1 WHAT IS IN THIS LEAFLET 1. What Efamat is used for 2. How Efamat works 3. Before you use Efamat 4. How to use Efamat 5. While you are using it 6. Side Effects 7. Storage and Disposal of Efamat 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT EFAMAT IS USED FOR Efamat contains an active ingredient efavirenz which used to treat HIV infection. Efamat taken in combination with other antiretroviral medicines reduces the amount of the virus in the blood. HOW EFAMAT WORKS Efamat is a member of a class of antiretroviral medicines called non- nucleoside reverse transcriptase inhibitors (NNRTIs). It is an antiretroviral medicine that fights HIV infection by reducing the amount of virus in blood. BEFORE YOU TAKE EFAMAT - _When you must not use it _ Do not take Efamat if you are allergic to any of the ingredients in Efamat tablets. Efamat should not be taken with some other medicines. (See Taking other medicines) - _Before you start use it _ Inform your doctor about any past or present medical problems, including: liver disease (for example, chronic hepatitis B or C) or allergies, seizures, mental illness, or substance or alcohol abuse any medications, vitamins, or nutritional supplements including St. John’s wort (Hypericum perforatum). Inform your doctor if you are breast- feeding a baby, pregnant, or intend to become pregnant. Tell your doctor if you are taking a medicine that contains efavirenz. Efamat should not be taken together with other medicines that contain efavirenz. Women should notify their physician if they become pregnant while taking Efamat. If you could get pregnant while receiving Efamat, a reliable form of barrier contraception should always be used with other methods of contraception including oral (pill) or other hormonal contraceptives (e.g., implants, injection). Efavirenz, may remain in your blood for a time after ther Baca dokumen lengkapnya
LABEL CLAIM EFAMAT TABLETS 200 MG Each film coated tablet contains Efavirenz USP 200 mg EFAMAT 200 (EFAVIRENZ TABLETS 200MG) PRODUCT DESCRIPTION: Peach colored oval shaped, film coated tablets, debossed with ‘3X’ on one side and ‘M’ on other side. LIST OF EXCIPIENTS: Cellulose Microcrystalline, Croscarmellose sodium, Hydroxypropyl cellulose, Sodium lauryl Sulfate, Lactose monohydrate, Magnesium Stearate, Film coat {Hypromellose, Titanium dioxide, Polyethylene glycol 400, Iron oxide yellow, Iron oxide red}. THERAPEUTIC INDICATIONS Efavirenz is indicated in antiviral combination treatment of HIV 1 infected adults, adolescents and children. POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: The recommended dosage of Efavirenz in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs) is 600 mg orally, once daily. Efavirenz may be taken with or without food, as desired. In order to improve the tolerability of nervous system side effects, bedtime dosing is recommended during the first two to four weeks of therapy and in patients who continue to experience these symptoms. (see SIDE EFFECTS). CONCOMITANT ANTIRETROVIRAL THERAPY: Efavirenz must be given in combination with other antiretroviral medications. ADOLESCENTS AND CHILDREN (17 YEARS AND UNDER): The recommended dose of Efavirenz incombination with a protease inhibitor and/or NRTIs for patients 17 years of age and under is described in Table 1. Efavirenz tablets should only be administered to children who are able to reliably swallow tablets. Efavirenz tablets may be taken with or without food, as desired. Efavirenz has not been adequately studied in children under the age of 3 years or children weighing less than 13 kg. TABLE 1 PEDIATRIC DOSE TO BE ADMINISTERED ONCE DAILY BODY WEIGHT (Kg) EFAVIRENZ TABLETS DOSE (MG) 13 to <15 200 15 to < 20 250 20 to < 25 300 25 to < 32.5 350 32.5 to < 40 400 ≥40 600 Efamat Tablets are available in two strengths of 200mg and 600mg. They are not able to deliver all approved dose Baca dokumen lengkapnya